LABELS · 49603d9a-adbb-4f38-a35f-d4e969c92a79

Cysview

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-06-03
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) based on a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see Warnings and Precautions (5.2) ] . CYSVIEW is an optical imaging agent indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the basis of a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. ( 1 , 5.2 )

Full extracted label fields

application numbers

NDA022555

boxed warning exact

brand names

Cysview

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5aeed40d-6841-4adf-8940-f51d439fdfa3

generic names

HEXAMINOLEVULINATE HYDROCHLORIDE

49603d9a-adbb-4f38-a35f-d4e969c92a79

indications and usage exact

1 INDICATIONS AND USAGE CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) based on a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see Warnings and Precautions (5.2) ] . CYSVIEW is an optical imaging agent indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the basis of a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. ( 1 , 5.2 )

indications and usage tables exact

is original packager

true

manufacturer names

Photocure Inc.

matched search terms

cancer
carcinoma

package ndcs

10511-3001-2

product ndcs

10511-3001

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration, Blue Light Imaging Devices ( 2.4 ) 6 / 2026 Contraindications, gross hematuria ( 4 ) - Removed 6/2026

record type

complete_spl_indications_section_candidate

routes

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 200
total: 830

terms

https://open.fda.gov/terms/

sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249603d9a-adbb-4f38-a35f-d4e969c92a79%22

spl effective date

2026-06-03

spl effective time

20260603

spl set id

5aeed40d-6841-4adf-8940-f51d439fdfa3

spl version

substance names

uniis

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA022555
payload
all indexed label documents
Appl No
022555
Application Docs Date
2010-06-03 00:00:00
Application Docs ID
17702
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022555s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
022555
Application Docs Date
2016-08-02 00:00:00
Application Docs ID
17703
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022555s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
022555
Application Docs Date
2018-02-16 00:00:00
Application Docs ID
52659
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022555s005lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
022555
Application Docs Date
2026-06-23 00:00:00
Application Docs ID
86335
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022555s006lbl.pdf
Submission No
6
Submission Type
SUPPL
all submission records
Appl No
022555
Review Priority
PRIORITY
Submission Class Code ID
12
Submission No
1
Submission Status
AP
Submission Status Date
2010-05-28 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
022555
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
3
Submission Status
AP
Submission Status Date
2012-11-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022555
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
4
Submission Status
AP
Submission Status Date
2016-07-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022555
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
5
Submission Status
AP
Submission Status Date
2018-02-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022555
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
6
Submission Status
AP
Submission Status Date
2026-06-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA022555
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022555
has approved submission record
true
latest approved submission date
2026-06-18
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
022555
Application Docs Date
2026-06-23 00:00:00
Application Docs ID
86335
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022555s006lbl.pdf
Submission No
6
Submission Type
SUPPL
official application record
Appl No
022555
Appl Public Notes
Appl Type
NDA
Sponsor Name
PHOTOCURE ASA
openfda application present
true
products
Active Ingredient
HEXAMINOLEVULINATE HYDROCHLORIDE
Appl No
022555
Drug Name
CYSVIEW KIT
Form
FOR SOLUTION;INTRAVESICAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
100MG/VIAL
marketing status
Prescription

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA022555

brand names

Cysview

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement
positive_statement_also_contains_qualification_review_required

clinical review status

pending

content role

positive_indication_candidate

context span

end: 649
end exclusive: true
exact text: 1 INDICATIONS AND USAGE CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) based on a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see Warnings and Precautions (5.2) ] . CYSVIEW is an optical imaging agent indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the
label id: 49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start: 0

current approval status

not_reconciled

duplicate text group

dup-24a591455b7812bcbb04

extraction review status

automated_candidate_pending_source_review

generic names

HEXAMINOLEVULINATE HYDROCHLORIDE

ind-span-abb226829965446547d0

label id

49603d9a-adbb-4f38-a35f-d4e969c92a79

positive predicate support span

end: 44
end exclusive: true
exact text: is indicated
label id: 49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start: 32

qualifier mentions

context exact
inoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) based on a prior cystosc
kind
age
polarity
not_inferred
span
end
156
end exclusive
true
exact text
adult patients
label id
49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit
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source array index
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source field
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source text sha256
c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start
142

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 449
end exclusive: true
exact text: 1 INDICATIONS AND USAGE CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) based on a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see Warnings and Precautions (5.2) ] .
label id: 49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249603d9a-adbb-4f38-a35f-d4e969c92a79%22

spl effective date

2026-06-03

spl set id

5aeed40d-6841-4adf-8940-f51d439fdfa3

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 2 · positive indication candidate

application numbers

NDA022555

brand names

Cysview

classification reasons

explicit_positive_indication_predicate
diagnostic_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 880
end exclusive: true
exact text: copy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see Warnings and Precautions (5.2) ] . CYSVIEW is an optical imaging agent indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the basis of a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. ( 1 , 5.2 )
label id: 49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start: 250

current approval status

not_reconciled

duplicate text group

dup-4622b466db3e408e3573

extraction review status

automated_candidate_pending_source_review

generic names

HEXAMINOLEVULINATE HYDROCHLORIDE

ind-span-14759d288be625cb35b2

label id

49603d9a-adbb-4f38-a35f-d4e969c92a79

positive predicate support span

end: 495
end exclusive: true
exact text: is an optical imaging agent indicated
label id: 49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start: 458

qualifier mentions

context exact
inoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the basis of a prior
kind
age
polarity
not_inferred
span
end
607
end exclusive
true
exact text
adult patients
label id
49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start
593

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 868
end exclusive: true
exact text: CYSVIEW is an optical imaging agent indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the basis of a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.
label id: 49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start: 450

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249603d9a-adbb-4f38-a35f-d4e969c92a79%22

spl effective date

2026-06-03

spl set id

5aeed40d-6841-4adf-8940-f51d439fdfa3

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

diagnostic_candidate

Passage 3 · unclassified context

application numbers

NDA022555

brand names

Cysview

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 880
end exclusive: true
exact text: stoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. ( 1 , 5.2 )
label id: 49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start: 669

current approval status

not_reconciled

duplicate text group

dup-7be5af7e03a698f889e4

extraction review status

automated_candidate_pending_source_review

generic names

HEXAMINOLEVULINATE HYDROCHLORIDE

ind-span-bc35347dceeee269195b

label id

49603d9a-adbb-4f38-a35f-d4e969c92a79

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 880
end exclusive: true
exact text: ( 1 , 5.2 )
label id: 49603d9a-adbb-4f38-a35f-d4e969c92a79
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c2f47a8425a630b2a9a9272a3e60505e977dce5a38c899e4c2efd0e12d91b5ef
start: 869

source url

https://api.fda.gov/drug/label.json?search=id%3A%2249603d9a-adbb-4f38-a35f-d4e969c92a79%22

spl effective date

2026-06-03

spl set id

5aeed40d-6841-4adf-8940-f51d439fdfa3

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Preserved source evidence · Not medical advice